Psychiatric adverse events reported after COVID-19 vaccination in the European Union (EU), the United States (US) and the United Kingdom (UK)

Abstract

IntroductionSeveral psychiatric adverse events can occur after vaccination. Passive surveillance reporting systems can support the identification of rare adverse events and contribute to hypothesis generation for potential causal associations.ObjectivesTo describe the psychiatric adverse reactions associated with various COVID-19 vaccines reported in the WHO database (VigiBase®)MethodsWe for individual case reports (ICSRs) for “Psychiatric disorders” linked to COVID-19 vaccines authorized in the EU, the US and the UK. Reporting rates were calculated using the number of administered doses as a denominator. Disproportional reporting was investigated through frequentist and Bayesian approaches by the calculation the information component (IC) for adverse psychiatric adverse not included in the vaccine label.Results63322 ICSRs including 76,163 psychiatric adverse events were identified, 21878 (34.6 %) were serious events. Mean age in the reports was 48.8 years old (SD: 17.8) and involved 44441 (70.2%) female and 17975 (28.4%) women; sex was not specified in 906 (1.4%) reports. Rate of reported psychiatric adverse events per million administered doses were 52.0, 110.3, 164.8 and 170.8 for Tozinameran/Cominarty (Pfizer-BioNTech), Elasomeran (Moderna), Vaxzevria (AstraZeneca) and Ad26.COV2-S (Janssen) vaccines respectively. UK recorded the highest rates. The most frequently reported events were insomnia (21.6%), confusional state (13.6%) and anxiety (13.5%). Disproportionality was found for: habit cough (IC:3.6), clinomania (IC: 2.2), exploding head syndrome (IC: 2.2) and autoscopy (IC: 2.1).ConclusionsRates of reported psychiatric adverse events are very low. Doctors and patients should be aware of these potential adverse reactions. Continuing monitoring of emerging potential safety signals is advised.DisclosureNo significant relationships.